康泰生物(300601.SZ):凍幹人用狂犬病疫苗(人二倍體細胞)申請生產註冊獲受理
格隆匯11月8日丨康泰生物(300601.SZ)公佈,公司全資子公司北京民海生物科技有限公司(“民海生物”)研發的凍幹人用狂犬病疫苗(人二倍體細胞)申請生產註冊獲得國家藥品監督管理局出具的《受理通知書》,受理號: CXSS2101046國。
凍幹人用狂犬病疫苗(人二倍體細胞)用於預防狂犬病。狂犬病是由狂犬病毒引起的一種人獸共患的急性傳染病,臨牀表現為特有的恐水、怕風、嚥肌痙攣、進行性癱瘓等,一旦有症狀出現,病死率接近100%。接種狂犬病疫苗是控制和預防狂犬病的有效方式。民海生物研發的凍幹人用狂犬病疫苗(人二倍體細胞)採用人二倍體細胞製備,具有生產工藝先進、質量穩定、良好的安全性、免疫原性和免疫持久性等優勢。國內對狂犬病疫苗的需求量較大,該疫苗市場前景良好。
根據國家藥品註冊管理相關法規,凍幹人用狂犬病疫苗(人二倍體細胞)申請生產註冊獲得受理後,還需經過技術審評、臨牀試驗現場核查、生產現場檢查等相關審評審批程序後方可獲得批准。
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